MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD NEEDLE ECLIPSE 25X1 RB; ECLIPSE NEEDLE

Catalog Number	305837
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd needle eclipse 25x1 rb safety mechanism failed.The following information was provided by the initial reporter: "issue with a bd eclipse needle, the safety popped off during engagement and the user was stuck." response received on 31-oct-2023: "we have 600 of these needles from the same lot removed from use and could send to you to evaluate if you could provide a shipping label.We do not have photos, what occurred was on 10/24/2023 the pink plastic safety ¿popped off¿ during one-handed engagement of the safety using the right hand.The needle then came down upon and stuck the employees left hand.This was a used needle so the needle and the safety which broke off were both discarded into a sharps box.".
Additional Manufacturer Narrative
Investigation summary: 6 cartons of material 305837 needles were received and tested by our quality team.The safety mechanisms were sampled and individually tested and there were no issues observed.The complaint could not be verified and the root cause of this failure remains unknown.There were no notifications identified during the production quality review that may have contributed to the safety shield popping off.All inspections were complete and acceptable.
Event or Problem Description
Samples received.

• Brand Name: BD NEEDLE ECLIPSE 25X1 RB
• Common Device Name: ECLIPSE NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18190880
• Report Number: 1920898-2023-00786
• Device Sequence Number: 12397505
• Product Code: FMI
• UDI-Device Identifier: 00382903058372
• UDI-Public: (01)00382903058372
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305837
• Device Lot Number: 2139845
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown